Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
www.fda.gov →Official Site

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
Endologix
AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment...
Medical Devices·0 affected·Dec 27, 2016
High RiskFDA
Endologix
AFX Endovascular AAA System, Endoleak Type IIIA
Medical Devices·40,967 affected·Dec 27, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
Medical Devices·107 affected·Dec 27, 2016
High RiskFDA
Endologix
AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with...
Medical Devices·40,967 affected·Dec 27, 2016
High RiskFDA
Farm To Market Foods
Farm to Market Foods Smoked Ham Dinner #1977 Holiday Ingredients: Smoked Spiral Diced Ham, Mashed Potatoes, Orange Cranberry Relish, Broc...
Produce·3,312 affected·Dec 24, 2016
High RiskFDA
Farm To Market Foods
Farm to Market Foods Smoked Turkey #1975 Holiday Ingredients: Smoked Turkey, Cornbread Dressing, Orange Cranberry Relish, Turkey Giblet G...
Meat & Poultry·7,302 affected·Dec 24, 2016
High RiskFDA
Farm To Market Foods
Farm to Market Foods Green Bean Casserole Code #1958 Net Wt. 6/1.95 lb. Trays with 6/.05 oz. Frenchs Fried Onions; Farm to Market Foods G...
Produce·15,892 affected·Dec 24, 2016
High RiskFDA
Authentic Alaska
Alaska Salmon Bites (jerky), Rhubarb & Raspberries flavor, Dear North brand, Item # 2002, net wt. per pouch: 2 oz. UPC 8 15036 02002 7.
Seafood·100 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavi...
Medical Devices·1 affected·Dec 23, 2016
High RiskFDA
Becton Dickinson & Company
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton...
Diabetes Devices·57,750 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the c...
Medical Devices·27 affected·Dec 23, 2016
High RiskFDA
Elekta, Inc.
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan ra...
Medical Devices·433 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid ...
Medical Devices·2,933 affected·Dec 23, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView X upgraded to XCT 882454
Medical Devices·0 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the ch...
Medical Devices·245 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the che...
Medical Devices·3 affected·Dec 23, 2016
High RiskFDA
Schreiber Food International
Ambrosia Quality Foods Brand 4/1 gallon Worcestershire Sauce Net 128 Fl. Oz.
Food·5,828 affected·Dec 22, 2016
CriticalFDA
Bickel's Snack Foods Inc
Bon Ton-Sour Cream & Onion Flavored Potato Chips sold in 2.75 oz, 1.5 oz. bags
Dairy·2 affected·Dec 22, 2016
CriticalFDA
Bickel's Snack Foods Inc
Bickel's Sour Cream & Onion Flavored Potato Chips sold in .75 oz., 2 oz., 7 oz., and 8.5 oz. bags.
Dairy·75 affected·Dec 22, 2016
CriticalFDA
Bickel's Snack Foods Inc
Troyer- Sour Cream & Onion Flavored Potato Chips sold in 2oz., and 8.5 oz. bags.
Dairy·2 affected·Dec 22, 2016
CriticalFDA
Bickel's Snack Foods Inc
Key Foods - Sour Cream & Onion Flavored Potato Chips sold in 6 oz. bags
Dairy·6 affected·Dec 22, 2016
CriticalFDA
Bickel's Snack Foods Inc
Dan Dee - Sour Cream & Onion Flavored Potato Chips sold in 7/8 oz., 2 oz., and 8.5 oz. bags
Dairy·7 affected·Dec 22, 2016
High RiskFDA
Safeway Inc
Signature Kitchens Tuna Chunk Light 20 oz. (4 pack), 12 oz., 5 oz. UPC Codes: 2113033549, 2113035609, 2113035612
Seafood·265 affected·Dec 22, 2016
CriticalFDA
Bickel's Snack Foods Inc
Cabana- Sour Cream & Onion Flavored Potato Chips sold in 5 oz. bags
Dairy·5 affected·Dec 22, 2016
High RiskFDA
Aurobindo Pharma Usa Inc
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 240...
Oral Drugs·47,040 affected·Dec 22, 2016
High RiskFDA
Sandoz Incorporated
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Oral Drugs·96 affected·Dec 22, 2016
RecallFDA
Vintage Pharmaceuticals Llc, Dba Qualitest Pharmaceuticals
TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5...
Oral Drugs·1,200 affected·Dec 22, 2016
High RiskFDA
Roxane Laboratories, Inc.
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Oral Drugs·6,493 affected·Dec 22, 2016
High RiskFDA
Flower Orthopedics Corporation
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Medical Devices·0 affected·Dec 22, 2016
High RiskFDA
Tosoh Smd Inc
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware bet...
Medical Devices·34 affected·Dec 22, 2016
High RiskFDA
Agfa Healthcare Corp.
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to docume...
Medical Devices·10 affected·Dec 22, 2016
High RiskFDA
Mako Surgical Corporation
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Medical Devices·777 affected·Dec 22, 2016
CriticalFDA
Fromi Usa Corp C/o Natixis Prame
Tomme Brebis Fedou, Net Wt. 9.7lb (case)/Net Wt 4.85 lb per unit, Item number 702084
Food·2 affected·Dec 21, 2016
High RiskFDA
Rich Products Corp
Signature SELECT Vanilla Ice Cream & White Cake ICE CREAM CAKE , NET WT 4 LB 13 OZ, KEEP FROZEN, UPC 021130 114641, Product Code 06620 ---
Dairy·6,632 affected·Dec 21, 2016
High RiskFDA
Rich Products Corp
RICH'S 1/4 Sheet White Cake with Vanilla Ice Cream Cake, KEEP FROZEN, UNIT NET WT: 60 OZ (3 LB 12 OZ), COUNT: 4 x 1/4 SHEET CAKES, NET CA...
Dairy·6,632 affected·Dec 21, 2016
CriticalFDA
Fromi Usa Corp C/o Natixis Prame
Soureliette cheese, Net Wt 3.969 lb (case)/ Net Wt 1.323 lb per unit, Item number 707116
Dairy·7 affected·Dec 21, 2016
CriticalFDA
Fresh Express, Inc.
Fresh Express Hearts of Romaine salad, 9 oz., clear/labeled salad bag/ 6 bags per case
Produce·100 affected·Dec 21, 2016
High RiskFDA
Capitol City Specialties Company
the Peanut Principle, Dashing Thru the Dough, Gourmet Chocolate Chip Cookie Dough Peanut Butter, NET WT 16oz, UPC 609207898788
Dairy·900 affected·Dec 21, 2016
CriticalFDA
J M Exotic Foods Inc
WOOD FARMS Ranch dressing, EX418, NET WT: 6.4 oz, UPC 9172850097
Food·144 affected·Dec 21, 2016
High RiskFDA
Rich Products Corp
Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy vanilla ice cream, NET WT 4 LB 8 OZ, KEEP FROZEN, UPC 0 ...
Dairy·6,632 affected·Dec 21, 2016
CriticalFDA
J M Exotic Foods Inc
Tupperware, Southwest Chipotle Seasoning, Assaisonnement Chipotle du sud-ouest, NET WT. 2.0 OZ. (56g)
Snacks & Candy·115 affected·Dec 21, 2016
High RiskFDA
Teva Pharmaceuticals Usa
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, S...
Oral Drugs·133,601 affected·Dec 21, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in ...
Diagnostic Devices·1,379 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008K@home Series : Hemodialysis System
Medical Devices·1,400 affected·Dec 21, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·279 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008K2 Series : Hemodialysis System
Medical Devices·60,151 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008T Series Hemodialysis System
Medical Devices·65,361 affected·Dec 21, 2016
RecallFDA
Beckman Coulter Inc.
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. Auto...
Medical Devices·4 affected·Dec 21, 2016